Status:
UNKNOWN
Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Diabetes Mellitus, Type 2
Dose-Response Relationship, Drug
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The purpose of this ...
Detailed Description
two hundred and forty primary diabetic patients will be expected to be recruited, which were divided into different groups in a randomized, doubled blind, dose-paralleled-control multi-centre clinical...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 2 diabetes mellitus
- 30-65 years old
- HbA1c≥7.0%, and FPG\>7.0 mmol/L, but \<13.9 mmol/L or 2hPG\>11.1 mmol/L
- Informed consent has been signed
- Dampness and Heat in Spleen
Exclusion
- The patients accepted diabetic treatment for more than a month continuously
- The patients were treated by drugs in 3 week before they were given test drugs
- Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
- The contractive pressure \>160 mmHg or diastolic pressure \>100 mmHg
- Pregnant, preparing for pregnancy or breast-feeding women
- Mental patients
- The patients whose ALT or AST are \>100U/L,and BUN or Cr are abnormal.
- The patients who have serious heart, lung, liver, kidney and brain or other primary complications
- Allergic persons
- The patients who are attending other clinical trial
- The patients who have serious diabetic complications
- The patients who ever attended this clinical trial
- Alcohol and / or psychoactive substances, drug abuse and dependency
- The person maybe loss for some reason such as work or life condition according to the investigator's judgement
- The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable
- The patients who are eating some drugs or health food which can affect the body weight
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01219803
Start Date
August 1 2010
End Date
August 1 2014
Last Update
May 8 2012
Active Locations (4)
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1
Beijing Traditional Chinese Medicine Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100010
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
3
Ji Shui Tan Hospital of Beijing
Beijing, Beijing Municipality, China, 100035
4
Dongzhimen Hospital Attached to Beijing Traditional Chinese Medicine University
Beijing, Beijing Municipality, China, 100700